PD-L1 Expression in Lung Cancer (PELICAN)

NanoMab

Status and phase: Enrolling; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Diagnostic Test: [99mTc]-NM01 SPECT/CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04992715

2020-002809-26 (EudraCT Number)

PELICAN

Details and patient eligibility

About

This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using [99mTc]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).

Full description

A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or above
• Patients with histopathology confirmed untreated metastatic NSCLC scheduled for systemic anti-cancer therapy
• ECOG status ≤ 1
• Willingness and ability to comply with scheduled study visits and tests

Exclusion criteria

• Pregnant or breast-feeding women
• Concomitant uncontrolled medical conditions as per Investigator assessment
• > 3 months between IHC PD-L1 and study recruitment
• Significant abnormality of haematology (one or more of: Hb ≤ 90g/L, absolute neutrophil count (ANC) ≤1.5 x109/L, platelet count ≤75 x109/L)
• Significant abnormality of renal function (defined as Cockcroft-Gault calculated creatinine clearance ≤30 mL/min)
• Significant abnormality of liver function (one or more of: AST or ALT ≥2.5x ULN or ≥ 5x ULN if patient has liver metastases; total bilirubin ≥1.5xULN. In the case of patients with Gilbert's syndrome then direct bilirubin must be confirmed as ≤ ULN)
• Significant cardiovascular disease, including New York Heart Association (NYHA) heart failure ≥Class III, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina
• History of uncontrolled allergic reactions and/or have hypersensitivity to anti-PD-L1 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Metastatic Non-Small Cell Lung Cancer

Experimental group

Description:

Subjects with metastatic non-small cell lung cancer will be recruited as per protocol inclusion/exclusion criteria and will undergo \[99mTc\]-anti-PDL1 single-domain antibody (\[99mTc\]-NM-01) SPECT/CT imaging. \[99mTc\]-NM-01 SPECT/CT images will be compared to immunohistochemistry PD-L1 expression results.

Treatment:

Diagnostic Test: [99mTc]-NM01 SPECT/CT